Status:
UNKNOWN
Prospective Database Registry Study of Scoliosis in Children With Cerebral Palsy
Lead Sponsor:
Setting Scoliosis Straight Foundation
Collaborating Sponsors:
K2M, Inc.
Conditions:
Cerebral Palsy
Scoliosis
Eligibility:
All Genders
8-21 years
Brief Summary
The purpose of this study is to determine the radiographic and clinical outcomes of Scoliosis surgical and non-operative treatment in patients with Cerebral Palsy.
Detailed Description
Bracing severe neuromuscular scoliotic curves rarely serves as definitive treatment, thus most progressive curves require surgical intervention in order to sustain or improve sitting (or ambulatory) a...
Eligibility Criteria
Inclusion
- Patient age 8-21 years
- Diagnosis of Cerebral Palsy (standard definition of any brain injury before the age of 3) with total body involvement - any functional level
- Coronal Curve \>50 degrees on sitting film (as measured by 'greatest Cobb') OR Kyphotic curve \>70 degrees on sitting film (as measured by T5-T12) AND
- A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion).
- OR
- • A spinal fusion is not being undertaken (Non-Operative cohort) either because the family has refused surgery or because it is not recommended at this point or surgery is recommended but is not being undertaken because they are on a waiting list, and are being enrolled as a non-op patient because they will be on the waiting list for \>18 months.
Exclusion
- Previous operated scoliotic spine deformity
- Diagnosis of Rett's Syndrome
- Concomitant lower extremity surgery (within 3 months of spinal fusion)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00680264
Start Date
June 1 2008
End Date
December 1 2025
Last Update
November 21 2023
Active Locations (15)
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1
Rady Children's Hospital
San Diego, California, United States, 92123
2
A.I. Dupont Hospital for Children
Wilmington, Delaware, United States, 19803
3
Miami Children's Hospital
Miami, Florida, United States, 33155
4
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21287